PDA WEEK – DENVER, CO – MARCH 2026
Gateway Analytical is proud to attend the 2026 PDA Annual Meeting Week in Denver, Colorado alongside our parent company, Aptar Pharma. Together, we will highlight how integrated device components and analytically robust data packages create a solid foundation for safe, compliant, and innovative drug products.
As regulatory expectations evolve, development and QC teams face growing demands for defensible particulate and CCI data, especially when working with new modalities, novel delivery systems, and Difficult-to-Inspect Products (DIPs). Ensuring your analytical strategy is built to withstand intensified scrutiny is essential for success in 2026 and beyond.
Bridging Device Innovation and Analytical Defensibility
From early development through commercial deployment, regulatory expectations surrounding particulate control and container closure performance continue to increase. During PDA Week, our team will focus on how to strengthen strategies in key risk areas:
Visible Particulate Characterization
Through advanced forensic techniques, including SEM-EDS and micro-Raman spectroscopy, we help teams investigate, identify, and resolve particulate “unknowns” that could otherwise lead to batch holds or release delays.
Subvisible Particle Testing & Scientific Bridging
As CGT, LNP, and mRNA therapies introduce new challenges, low-volume method verification and scientifically appropriate bridging strategies become essential. Our approach preserves precious API while generating high-quality, defensible data.
Container Closure Integrity (CCI) Testing
Ensuring functional suitability across the full container-closure-delivery system is critical for regulatory approval. We support teams in evaluating closure performance using cGMP-aligned CCI technologies and risk-based methodologies.
Unified Solutions for Complex Modalities
Our combined expertise—spanning analytical chemistry, materials science, and elastomeric component engineering—equips drug developers with actionable solutions for:
· System-Level Optimization: Evaluating device and closure interactions in real-world patient environments.
· Complex Modality Testing: Tailored workflows for CGT, LNP, and mRNA programs requiring low-volume and high-sensitivity analytical methods.
· Forensic Root-Cause Resolution: Rapid identification of particulate contaminants to turn a batch hold into a defensible path forward.
See Our Technology Lab at PDA Week
Don’t miss your opportunity to experience live instrument demonstrations featuring industry-leading tools from Lighthouse Instruments and PTI. These technologies form the backbone of robust CCI and particulate-inspection strategies adopted by leading pharma and biotech companies worldwide.
Whether you’re refining a USP <788>/<787> testing strategy, building a DIP-resilient inspection approach, or preparing for regulatory submission, our team is ready to help you accelerate your readiness.
Connect With Us in Denver – PDA WEEK – DENVER, CO – MARCH 2026
Don’t wait for an inspection to find a gap in your analytical strategy. Start preparing for your 2026 analytical strategy today.
Gateway Analytical — Scientific Clarity for Complex Problems.
